AzTrials
AzTrials

Depression, UnipolarEXDEPNCT02874833

Exercise for Depression

A study testing Exercise in people with Depression, Unipolar and Bipolar Disorder, run by Johannes Gutenberg University Mainz at 2 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

A randomized single-blinded prospective study to evaluate the efficacy of an individualized supervised 8-week exercise program in subjects with moderate to severe depressive episodes compared to treatment-as-usual Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Depression, Unipolar, Bipolar Disorder
What is being tested?
Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
2 sitesGermany
Study dates
Jul 2016to Feb 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local subject privacy regulations.
  • Aged 18 to 65 years old, inclusive, at the time of informed consent.
  • Montral Cognitive Assessment (MoCA) > 26 to exclude cognitive impairment.
  • Apart from a clinical diagnosis of major depression or bipolar affective disorder, the subject must be in good health as determined by the Investigator, based on medical history and physical examination.
  • QIDS scores > 5

Who cannot join

  • Use of antidepressive medications or benzodiazepines at doses that have not been stable for at least 6 weeks prior to Screening
  • Psychotherapy that started less than 8 weeks prior to Screening
  • Any clinically significant psychiatric illness other than major depression or bipolar affective disorder
  • Transient ischemic attack or stroke or any unexplained loss of consciousness within 1 year prior to Screening
  • Any uncontrolled medical or neurological/neurodegenerative condition that, in the opinion of the Investigator, might impair treatment compliance and adherence
  • History of unstable angina, myocardial infarction, chronic heart failure (New York Heart Association Class III or IV), or clinically significant conduction abnormalities (e.g., unstable atrial fibrillation) within 1 year prior to Screening
Show all 18Show fewer
  • Clinically significant 12-lead ECG abnormalities, as determined by the Investigator
  • Uncontrolled hypertension defined as: average of 3 systolic blood pressure [SBP]/diastolic blood pressure [DBP] readings > 165/100 mmHg at Screening
  • History of malignancy or carcinoma, with the following exceptions:
  • Subjects with cancers in remission more than 5 years prior to Screening. ii) Subjects with a history of excised or treated basal cell or squamous carcinoma. iii) Subjects with prostate cancer in situ.
  • History of seizure within 2 years prior to Screening.
  • Recent history (within 1 year of Screening) of alcohol or substance abuse as determined by the Investigator, a positive urine drug (due to non-prescription drug) or alcohol test at Screening
  • Clinically significant systemic illness or serious infection (e.g., pneumonia, septicemia) within 30 days prior to or during Screening
  • History of human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis B virus (HBV)
  • Any other medical conditions (e.g., renal disease) that are not stable or controlled, or, which in the opinion of the Investigator, could affect the subject's safety or interfere with the study assessments
  • Female subjects who are pregnant or currently breastfeeding
  • Participation in another study
  • Other unspecified reasons that, in the opinion of the Investigator or Biogen, make the subject unsuitable for enrollment

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

  • Department of Psychiatry and Psychotherapy, University Medical Center, Mainz

    Mainz, Rhineland-Palatinate, 55099

  • Department of Sports Medicine, Johannes Gutenberg University, Mainz

    Mainz, Rhineland-Palatinate, 55099

Other trials in Germany

About this study

Official title: The Efficacy of Exercise in Depressive Episodes of Unipolar Depression and Bipolar Affective Disorders

A randomized single-blinded prospective study to evaluate the efficacy of an individualized supervised 8-week exercise program in subjects with moderate to severe depressive episodes compared to treatment-as-usual

Read the detailed description

The purpose of this study is to assess the efficacy of a supervised and indvidualized 8-week exercise program compared to treatment-as-usual in subjects with a moderate or severe depressive episode in the context of unipolar depression or bipolar affective disorders. Numerous previous studies suggest that exercise may help to improve the symptoms of depression. Moreover, exercise was shown to enhance neuroplasticity in adults whereas depression results in decreased neuroplasticity. Here, we aim at elucidating whether a newly developed supervised, Internet-based, individualized exercise program of the Institute of Sports Science and the Department of Psychiatry and Psychotherapy at the University Mainz is more effective in reducing depressive symptoms than treatment-as-usual. Furthermore, this study will clarify if severely depressed subjects are able to adhere to an internet-based exercise therapy.

Being tested
Exercise
Keywords
Depression, Unipolar depression, Bipolar affective disorder, Exercise, Internet-based intervention
Medical subject headings
Depressive Disorder, Bipolar Disorder, Depression, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExerciseOther

    After performance diagnostics, participants will complete an 8-week supervised, individualized exercise program. Training will include up to 3 aerobic training sessions and up to two resistance training units per week.

Study groups in NCT02874833
Study groupRoleWhat they receive
Exercise GroupExperimentalExperimental arm type will assess whether a newly developed, supervised 8-week individualized, internet-based exercise therapy is effective in reducing depressive symptoms.
Receives: Other: Exercise
Treatment as usual groupNo interventionTreatment as usual. Other form of therapy (e.g. antidepressive medication) will not be affected.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Severity of depressive symptoms - Quick Inventory of Depressive Symptomatology - clinical rating-16 (QIDS C-16)

    Change of Score on the QIDS C-16 after 8 weeks compared to baseline.

    Measured: 8 weeks

  2. Severity of depressive symptoms - Quick Inventory of Depressive Symptomatology - self-report-16 (QIDS SR-16)

    Change of Score on the QIDS SR-16 after 8 weeks compared to baseline.

    Measured: 8 weeks

Secondary outcomes (9)

  1. Adherence of internet-based concept

    Adherence of internet-based concept using an own questionnaire. Participants respond at the end of every week how they managed their individualized exercise schedule in terms of number of realised training sessions, average heart rate and subjective perceived exertion.

    Measured: 8 weeks

  2. Placebo effect of exercise (QIDS-SR16)

    Change of Score on the QIDS-SR16 after one week of training to determine placebo effect of exercise.

    Measured: 8-10 days

  3. Placebo effect of exercise (QIDS-C16)

    Change of Score on the QIDS-C16 after one week of training to determine placebo effect of exercise.

    Measured: 8-10 days

  4. Peak oxygen uptake (VO2peak)

    Change of VO2peak after 8 weeks compared to baseline. Participants will be subjected to a step-wise treadmill test at baseline and after 8 weeks.

    Measured: 8 weeks

  5. Lactate threshold

    Change of lactate threshold using the baseline +1.5 mmol model after 8 weeks compared to baseline.

    Measured: 8 weeks

  6. Short form 36 (SF36) health survey questionnaire

    Change of score on the SF-36 after 8 weeks compared to baseline.

    Measured: 8 weeks

  7. General self efficacy questionnaire (GSE)

    Change of score on the GSE after 8 weeks compared to baseline.

    Measured: 8 weeks

  8. Global Clinical Issues (GCI)

    Change of score on GCI after 8 weeks compared to baseline.

    Measured: 8 weeks

  9. Circulating, cell-free DNA (cfDNA)

    Change of cfDNA concentrations after 8 weeks compared to baseline.

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2016 (estimated)
  2. Study startJul 2016
  3. Primary completionOct 2017
  4. Study completionFeb 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02874833
Sponsor's protocol ID
EXDEP_1
Acronym
EXDEP
Status last verified
Feb 2018
First submitted
8 Aug 2016
Last updated
1 Mar 2018
Results posted
No
Data monitoring committee
No

Publications

  • Cooney GM, Dwan K, Greig CA, Lawlor DA, Rimer J, Waugh FR, McMurdo M, Mead GE. Exercise for depression. Cochrane Database Syst Rev. 2013 Sep 12;2013(9):CD004366. doi: 10.1002/14651858.CD004366.pub6.

    PubMed 24026850

  • Malykhin NV, Coupland NJ. Hippocampal neuroplasticity in major depressive disorder. Neuroscience. 2015 Nov 19;309:200-13. doi: 10.1016/j.neuroscience.2015.04.047. Epub 2015 Apr 28.

    PubMed 25934030

  • van Praag H, Shubert T, Zhao C, Gage FH. Exercise enhances learning and hippocampal neurogenesis in aged mice. J Neurosci. 2005 Sep 21;25(38):8680-5. doi: 10.1523/JNEUROSCI.1731-05.2005.

    PubMed 16177036

  • Yau GS, Lee JW, Woo TT, Wong RL, Wong IY. Central Macular Thickness in Children with Myopia, Emmetropia, and Hyperopia: An Optical Coherence Tomography Study. Biomed Res Int. 2015;2015:847694. doi: 10.1155/2015/847694. Epub 2015 Jun 8.

    PubMed 26167504

  • Haller N, Lorenz S, Pfirrmann D, Koch C, Lieb K, Dettweiler U, Simon P, Jung P. Individualized Web-Based Exercise for the Treatment of Depression: Randomized Controlled Trial. JMIR Ment Health. 2018 Oct 12;5(4):e10698. doi: 10.2196/10698.

    PubMed 30314962

  • Pfirrmann D, Haller N, Huber Y, Jung P, Lieb K, Gockel I, Poplawska K, Schattenberg JM, Simon P. Applicability of a Web-Based, Individualized Exercise Intervention in Patients With Liver Disease, Cystic Fibrosis, Esophageal Cancer, and Psychiatric Disorders: Process Evaluation of 4 Ongoing Clinical Trials. JMIR Res Protoc. 2018 May 22;7(5):e106. doi: 10.2196/resprot.8607.

    PubMed 29789277

Questions about this trial

What is this clinical trial studying?

A study testing Exercise in people with Depression, Unipolar and Bipolar Disorder, run by Johannes Gutenberg University Mainz at 2 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Severity of depressive symptoms - Quick Inventory of Depressive Symptomatology - clinical rating-16 (QIDS C-16) (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02874833, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in